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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K924163
Device Name EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
Applicant
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact M CARPINELLA
Correspondent
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact M CARPINELLA
Regulation Number870.1220
Classification Product Code
DRF  
Date Received08/19/1992
Decision Date 09/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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